9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
artegral
FDA UDI
Merz Dental GmbH·D7091970700·anteriors; shade D3 light; mould BL
BAHADIR USA
FDA UDI
BAHADIR USA LLC·00859982006322·FILTER HOLDER FOR S/M/L PAPER FILTER
Inqwire Diagnostic Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
FREEALGIN
FDA 510(k)
FDA Class 2
·Dental
PRIMEWIRE PRESTIGE PLUS
FDA Adverse Event
Malfunction
·VOLCANO S.R.L.·Product code DQX·June 2, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·February 20, 2013
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN VALLEYLAB·Product code GEI·January 3, 2011
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·January 13, 2016